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Weekly Drug News Round Up - July 3, 2013

Brisdelle Approved as the First Non-Hormonal Treatment for Menopausal Hot Flashes

Until now, all other approved treatments for hot flashes contained only estrogen or an estrogen/progestin combination Read More...

Brisdelle (paroxetine mesylate) has been approved the U.S. Food and Drug Administration as the first non-hormonal treatment for moderate to severe hot flashes (vasomotor symptoms) associated with menopause. Brisdelle contains the selective serotonin reuptake inhibitor (SSRI) paroxetine commonly used to treat depression. Brisdelle contains 7.5 milligram (mg) of paroxetine and is taken once daily at bedtime. A 30-day supply of scored paroxetine tablets are available generically for $4.00 in many U.S. pharmacies, but in higher doses starting at 10 mg. Noven Pharmaceuticals announced Brisdelle will be available in pharmacies starting in November 2013.

FDA Approves Baxter’s Rixubis for Use in Hemophilia B

Rixubis is the first recombinant coagulation factor IX indicated specifically for routine prophylaxis to prevent bleeding Read More...

Hemophilia B, an inherited bleeding disorder caused by mutations in the Factor IX gene, affects roughly 3,300 people in the United States. The U.S. Food and Drug Administration has approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes, use around the time of surgeries, and routine use to prevent or reduce the frequency of bleeding episodes. In a clinical trial, patients in the prevention study had a 75 percent lower annual bleeding rate when compared to patients who have historically received on-demand treatment.

Exelon Patch Approved to Treat the Full Spectrum of Alzheimer’s Disease

Alzheimer’s disease is the most common form of dementia among people age 65 and older Read More...

In addition to the treatment of patients with mild to moderate levels of Alzheimer’s disease (AD) Exelon Patch (rivastigmine transdermal system) is now FDA-approved for the treatment of severe AD. In the ACTION trial, which looked at measures of cognition and daily function, Exelon Patch 13.3 milligram(mg)/24 hour(hr) demonstrated significant improvement in overall cognition and function in severe AD patients versus the 4.6 mg/24h dose when evaluated at the 24th week of treatment. Alzheimer's is an irreversible degeneration of the brain that causes disruptions in memory, cognition, personality, and other functions.

FDA Cracks Down On Illegal Online Pharmacies

Authorities seize offending websites and over $41 million in illegal medicines worldwide Read More...

The U.S. Food and Drug Administration, in concert with the Colorado U.S. Attorney’s Office, has seized and shut down more than 1,600 illegal pharmacy websites in an operation dubbed “Pangea”. The crackdown was in an effort to protect consumers from illegal, potentially dangerous, unapproved prescription medicines often sold online. Some of the medicines that were sold illegally included Avandaryl, Celebrex, “Levitra Super Force” and clozapine. FDA-approved versions of these medications exist in the U.S. but the online drugs were not legal. The FDA's Cybercrime Investigations Unit banner is now displayed on seized websites to help consumers identify them as illegal.

7 Out of 10 Americans Use a Prescription Medication: Study

Survey reveals concerning fact about opioid use in the U.S. Read More...

Antibiotics, antidepressants and painkillers are the most widely used medicines by Americans in a recent U.S. survey conducted by the Mayo Clinic. Seventy percent of Americans use at least one medication, and 20 percent take five or more medicines. The drugs were prescribed to both men and women in all age groups. Opioids, which rank third in use, were most common among young and middle-aged adults, which is concerning considering the addictive nature of opioids like oxycodone. Antidepressants were also common and suggests mental health is an important issue to focus on in the healthcare arena.

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